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This front page NY Times article is the second piece they ran about revelations provided by Jim Gottstein of PsychRights exposing Eli Lilly fraud about the psychiatric drug Zyprexa. PsychRights is a sponsor group in MindFreedom.

Drug Files Show Maker Promoted Unapproved Use

Date Published:

Dec 18, 2006 03:00 AM

Author:
ALEX BERENSON

Source:
NY Times

Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and biploar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.

The marketing documents, given to The New York Times by a lawyer
representing mentally ill patients, detail a multiyear promotional
campaign that Lilly began in Orlando, Fla., in late 2000. In the
campaign, called Viva Zyprexa, Lilly told its sales representatives to
suggest that doctors prescribe Zyprexa to older patients with symptoms
of dementia.

A Lilly executive said that she could not comment on specific
documents but that the company had never promoted Zyprexa for off-label
uses and that it always showed the marketing materials used by its
sales representatives to the Food and Drug Administration, as required by law.

“We have extensive training for sales reps to assure that they
provide information to the doctors that’s within the scope of the
prescribing information approved by the F.D.A.,” Anne Nobles, Lilly’s
vice president for corporate affairs, said in an interview yesterday.

Zyprexa is not approved to treat dementia or dementia-related
psychosis, and in fact carries a prominent warning from the F.D.A. that
it increases the risk of death in older patients with dementia-related
psychosis. Federal laws bar drug makers from promoting prescription
drugs for conditions for which they have not been approved — a practice
known as off-label prescription — although doctors can prescribe drugs
to any patient they wish.

Yet in 1999 and 2000 Lilly considered ways to convince primary care
doctors that they should use Zyprexa on their patients. In one
document, an unnamed Lilly marketing executive wrote that these doctors
“do treat dementia” but “do not treat bipolar; schizophrenia is handled
by psychiatrists.”

As a result, “dementia should be first message,” of a campaign to
primary doctors, according to the document, which appears to be part of
a larger marketing presentation but is not marked more specifically.

Later, the same document says that some primary care doctors “might prescribe outside of label.”

Ms. Nobles said that the company had never promoted its drug for any
conditions except schizophrenia and bipolar disorder. Older patients
who seem to have dementia may actually have schizophrenia that has gone
untreated, Ms. Nobles said.

Several psychiatrists outside the company said yesterday that they
strongly disagreed with Lilly’s claim. Schizophrenia is a severe
disease that is almost always diagnosed when patients are in their
teens or 20s. Its symptoms could not be confused with mild dementia,
these doctors said.

Zyprexa is by far Lilly’s best-selling product, with $4.2 billion in
sales in 2005, 30 percent of its overall revenues. About two million
people worldwide received it last year. Based in Indianapolis, Lilly is
the sixth-largest American drug company.

The issue of off-label marketing is controversial in the drug
industry. Nearly every company is under either civil or criminal
investigation for alleged efforts to expand the use of its drugs beyond
the specific illness or condition for which they are approved.

Lilly faces federal and state investigations over its marketing of
Zyprexa. In its annual report for 2005, Lilly said that it faced an
investigation by federal prosecutors in Pennsylvania and that the
Florida attorney general’s office had subpoenaed the company “seeking
production of documents relating to sales of Zyprexa and our marketing
and promotional practices with respect to Zyprexa.”

Since Lilly introduced Zyprexa in 1996, about 20 million patients
worldwide have received the drug, which helps control the
hallucinations and delusions associated with schizophrenia and severe
mania. But Zyprexa also causes weight gain in many patients, and the
American Diabetes Association found in 2004 that Zyprexa was more likely to cause diabetes than other widely used drugs for schizophrenia.

Lilly says that no link between Zyprexa and diabetes has been proven.

As part of the “Viva Zyprexa” campaign, in packets for its sales
representatives, Eli Lilly created the profiles of patients whom it
said would be suitable candidates for Zyprexa. Representatives were
told to discuss the patient profiles with doctors. One of the patients
was a woman in her 20s who showed mild symptoms of schizophrenia, while
another was a man in his 40s who appeared to have bipolar disorder.

The third patient was “Martha,” a widow with adult children “who
lives independently and has been your patient for some time.” Martha
was described as being agitated and having disturbed sleep, but without
the symptoms of paranoia or mania that typically marked a person with
schizophrenia or bipolar disorder.

Ms. Nobles said that Lilly had actually intended Martha’s profile to
represent a patient with schizophrenia. But psychiatrists outside the
company said this claim defied credibility, especially given Martha’s
age. Instead, she appeared to have mild dementia, they said.

“It’d be very unusual for this to be a schizophrenic patient,” said Dr. John March, chief of child and adolescent psychiatry at Duke University
medical center. “Schizophrenia is a disease of teenagers and young
adults.” Dr. March serves on Lilly’s scientific advisory board.

Diagnostic criteria for schizophrenia include delusions,
hallucinations, disorganized and incoherent speech, and grossly
disorganized behavior. They also include so-called negative symptoms
like social isolation and a flattening of the voice and facial
expressions.

The documents also show that Lilly encouraged primary care doctors
to treat the symptoms and behaviors of schizophrenia and bipolar
disorder even if the doctors had not actually diagnosed those diseases
in their patients. Lilly’s market research had found that many primary
care doctors did not consider themselves qualified to treat people with
schizophrenia or severe bipolar disorder.

The campaign was successful, the documents show. By March 2001,
about three months after the start of Viva Zyprexa, the campaign had
led to 49,000 new prescriptions, according to a presentation that
Michael Bandick, the brand manager for Zyprexa, gave at a national
meeting of Lilly sales representatives in Dallas. Mr. Bandick did not
say how many of those new prescriptions were for older patients with
dementia.

Over all, sales of Zyprexa doubled between 1999 and 2002, rising
from $1.5 billion to $3 billion in the United States. In 2002, the
company changed the name of the primary care campaign to “Zyprexa
Limitless” and began to focus on people with mild bipolar disorder who
had previously been diagnosed as depressed — even though Zyprexa has
been approved only for the treatment of mania in bipolar disorder, not depression.

In a 2002 guide for representatives, Lilly presented the profile of
“Donna,” a single mother in her mid-30s whose “chief complaint is, ‘I
feel so anxious and irritable lately.’ ” Several doctors’ appointments
earlier, she was “talkative, elated, and reported little need for
sleep.”

Lilly’s efforts to promote Zyprexa to primary care doctors disturbed
some physicians, the documents show. In August 2001, a doctor in
Virginia sent an e-mail message to Lilly and the F.D.A., complaining
about a presentation from a Lilly sales representative who had
discussed the hypothetical Martha with him.

The representative “presented an elderly female patient who was presented to her physician by her family complaining of insomnia, agitation, slight confusion, and had no physical finding to explain her
state,” the doctor wrote. The representative then suggested that the
doctor prescribe Zyprexa.

“I inquired what Zyprexa was indicated for she then indicated that
many physicians might prescribe an antipsychotic for this patient. I
then asked for her package insert and read to her that her product was
indicated for schizophrenia and bipolar mania — neither of which the
presented patient had been diagnosed with,” the doctor wrote.

He added that he had never contacted the F.D.A. before but was
“genuinely concerned about the promotion of this powerful drug to my
peer community of primary care physicians outside of its approved and
intended purpose.”

Tara Ryker, a spokeswoman for Lilly, said the company no longer uses
“Martha” or “Donna” in its marketing. “We are constantly developing new
promotional materials and new profiles,” she said.

The Zyprexa documents were provided to The Times by James B.
Gottstein, a lawyer who represents mentally ill patients and has sued
the state of Alaska over its efforts to force patients to take
psychiatric medicines against their will.

Mr. Gottstein said yesterday that the information in the documents
should be available to patients and doctors, as well as judges who
oversee the hearings that are required before people can be forced to
take psychiatric drugs.

“The courts should have this information before they order this
stuff injected into people’s unwilling bodies,” Mr. Gottstein said.

Lilly originally provided the documents, under seal, to plaintiffs
lawyers who sued the company claiming their clients developed diabetes
from taking Zyprexa. Last year, Lilly agreed to pay $700 million to
settle about 8,000 of the claims, but thousands more are pending. Mr.
Gottstein, who is not subject to the confidentiality agreement that
covers the product liability suits, subpoenaed the documents in early
December from a person involved in the suits.

The “Viva Zyprexa” documents also provide color about Lilly’s
efforts to motivate its sales force as they marketed Zyprexa — whose
generic name is olanzapine — to primary care doctors.

At the 2001 meeting in Dallas with Zyprexa sales representatives,
Mr. Bandick praised 16 representatives by name for the number of
prescriptions they had convinced doctors to write, according to a
script prepared in advance of the meeting. More than 100 other
representatives had convinced doctors to write at least 16 extra
prescriptions and thus “maxed out on a pretty sweet incentive,” he said.

We are MFI

Laura Delano - Psychiatric survivor blogger activist

Laura works as a peer specialist in the traditional mental health system and writes a blog at madinamerica.com, where she is sharing her story of recovery from psychiatry. After living with psychiatric labels for 13 years and taking psychotropic medications for ten of them, Laura says she found liberation in 2010 from her psychiatric diagnoses, from her reliance upon the mental health system, and from the once deep-seated belief that she was sentenced to a life-long "mental illness." Laura says, "I am proud to be a member of the MindFreedom International community for all MFI does to promote equality, justice, and civil rights for people who have been labeled 'mentally ill.'" (See 'Related Content' links below for link to Mad In America web site where Laura's blogs.)